Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:December 2016
End Date:October 2018

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A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder

To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a
selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor
(SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an
inadequate response to antidepressant therapy


Inclusion Criteria:

1. Adult patients, aged 18 years and above

2. A clinical diagnosis of major depressive disorder (MDD)

3. Is being treated with one of the following SSRI or SNRI antidepressants as
monotherapy:

- Citalopram

- Escitalopram

- Paroxetine

- Fluoxetine

- Sertraline

- Duloxetine

- Venlafaxine

- Desvenlafaxine

- Venlafaxine XR

4. Has a history of inadequate response to antidepressant treatments

Exclusion Criteria:

1. Patient has a psychotic disorder other than MDD

2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular,
respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
including cancer or malignancies, which would affect the patient's ability to
participate in the program

3. Patient has a history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation
are met. Patients may be excluded from the study based on these assessments (and
specifically if it is determined that their baseline health and psychiatric condition do
not meet all pre-specified entry criteria).
We found this trial at
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Berlin, New Jersey
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UAB
Birmingham, Alabama 35233
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Bradenton, Florida
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Charleston, South Carolina 29405
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Chicago, Illinois 60612
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Clinton, Utah 84015
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Dallas, Texas 75231
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Dallas, Texas 75231
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Decatur, Georgia 30030
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Garden Grove, California 92845
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Hoffman Estates, Illinois 60169
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Jacksonville, Florida 32256
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Las Vegas, Nevada 89102
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640 George Washington Highway
Lincoln, Rhode Island 02865
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Maitland, Florida 32751
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National City, California 91950
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New York, New York 10022
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Oakland, California 94612
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Oklahoma City, Oklahoma 73112
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Philadelphia, Pennsylvania 19104
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Richardson, Texas 75080
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Rochester, New York 14618
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609 West Dyke Road
Rogers, Arkansas 72758
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Saint Louis, Missouri 63141
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Sherman Oaks, California 91403
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Waukesha, Wisconsin 53188
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Wichita, Kansas 67214
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